federal_register: 2010-24295

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2010-24295 Draft Guidance for Industry and Investigators on Safety Reporting Requirements for Investigational New Drug Applications and Bioavailability/Bioequivalence Studies; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and investigators entitled "Safety Reporting Requirements for INDs and BA/BE Studies." This draft guidance is intended to help sponsors and investigators comply with the new requirements in the final rule entitled "Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans," published elsewhere in this issue of the Federal Register. 2010-09-29 2010 9 https://www.federalregister.gov/documents/2010/09/29/2010-24295/draft-guidance-for-industry-and-investigators-on-safety-reporting-requirements-for-investigational https://www.govinfo.gov/content/pkg/FR-2010-09-29/pdf/2010-24295.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and investigators entitled "Safety Reporting Requirements for INDs and BA/BE Studies." This draft guidance is intended to help sponsors and...  

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